FDA Adverse Event Malfunction Summary report: N

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

MDR report key: 4853283 · Received June 18, 2015

Report

Report Number: 3004209178-2015-66514
Event Type: Malfunction
Date Received: June 18, 2015
Date of Event: May 30, 2015
Report Date: May 30, 2015
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: OYC
PMA / PMN Number: P980022
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTONS DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. NO FROZEN SCREEN NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW, CRACKED BATTERY TUBE THREADS AND BROKEN RESERVOIR TUBE LIP.

Additional Manufacturer Narrative · 1

CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

Description of Event or Problem · 1

THE CUSTOMER REPORTED VIA PHONE CALL THAT SHE HAD A BUTTON ERROR ALARM ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE AT THE TIME WAS 137 MG/DL. CUSTOMER STATED THAT THE PUMP JUST STOPPED WORKING AND THE PUMP WAS SITTING ON HER WAIST WHEN SHE NOTICED THE BUTTON ERROR. CUSTOMER STATED THAT THE SCREEN WAS FROZEN FOR 5 MINUTES AND THEN THE BUTTON ERROR OCCURRED. CUSTOMER DECLINED TROUBLESHOOTING FOR THE FROZEN DISPLAY. CUSTOMER WAS ADVISED THAT THE PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ALSO ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
397309	PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP	INSULIN INFUSION PUMP / SENSOR AUGMENTED	OYC	MEDTRONIC PUERTO RICO OPERATIONS CO.	MMT-523NAS

Patients

Seq	Age	Sex	Outcome	Treatment
1	35 YR